A feasibility study and pilot randomised controlled trial to establish methods for assessing the acceptability, and clinical and cost-effectiveness of enhanced psychological care in cardiac rehabilitation services for patients with new onset depression compared with treatment as usual

Royal Devon & Exeter NHS Foundation Trust, UK0 sites84 target enrollmentMay 29, 2014

Overview

Registry

who.int

Start Date

May 29, 2014

End Date

July 31, 2016

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Royal Devon & Exeter NHS Foundation Trust, UK

•A pragmatic approach will be adopted, whereby adult patients (18 years or over) referred for cardiac rehabilitation based on local clinical referral protocols of participating rehabilitation teams will be screened for eligibility by a specialist nurse. This includes patients admitted with an Acute Coronary Syndrome, i.e. ST elevation myocardial infarction or non\-ST elevation myocardial infarction and unstable angina, and/or following a coronary revascularization procedure, i.e. coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). These currently constitute the majority of patients referred for rehabilitation. Within this group, eligible patients are those identified as experiencing a new episode of depression symptoms identified through nurse screening at the start of the comprehensive cardiac rehabilitation programme using the Patient Health Questionnaire\-9 (PHQ\-9 score of 10 or more).

•Current exclusion criteria as of 12/11/2014:
•The following patient exclusion criteria will be applied during routine cardiac rehabilitation screening by a nurse specialist. Patients who report having been actively treated for depression (psychological or drug therapy) within 6 months before the acute cardiac event will be excluded. The nurse will also exclude patients where there is evidence of alcohol or drug dependency, being acutely suicidal, or having poorly controlled bipolar disorder or psychosis/psychotic symptoms based on a clinical review (and seeking external confirmation from the general practitioner or other clinicians as required).
•Previous exclusion criteria:
•The following patient exclusion criteria will be applied during routine cardiac rehabilitation screening by a nurse specialist. Patients who report having been actively treated for depression (psychological or drug therapy) within 6 months before the acute cardiac event will be excluded. The nurse will also exclude patients where there is evidence of alcohol or drug dependency, being acutely suicidal or cognitively impaired (e.g. diagnosed dementia), or having a bipolar disorder or psychosis/psychotic symptoms based on a clinical review (and seeking external confirmation from the general practitioner or other clinicians as required).